Research

Study Tools and Templates

SOME OF THE TOOLS AND TEMPLATES ON THIS SITE MAY NOT BE THE MOST RECENT VERSION. CONTACT THE EQUIP OFFICE AT 857-355-5308 IF YOU HAVE QUESTIONS ABOUT WHETHER A NEWER VERSION IS AVAILABLE.

The study tools and templates provided are intended to help research teams:

Document required information

Organize study documents

Track study procedures

First, take the time to think about what data is required, and only then should you select a template to build from. Do not let a template influence what data you will collect, but rather modify the template to collect the data you need. Once you have a template selected, customize the form to fit the specific needs of the study and research team. When tailoring the template, remember to:

Use a legible font and font size

Provide ample space to enter complete and legible data

Only collect data that is required and useful for the study and staff (remove fields if they will not be used)

Design the form to be user-friendly -- easy to update, understand and maintain

Consider where the form will be filed and how it will be updated (electronically or paper) - must be safe and secure, but accessible for updating and reference.

To use any of our study templates below, click on the template name to open the document in MS Word format. For more detailed description and ideas on how to use the template, click on the corresponding Guidance document (if available).

Staff Signature Log: Lists all approved staff, documents their signature and the time frame each staff member was delegated specific tasks for the study. For guidance in using this template, click here.

Subject Eligibility Checklist: Documents that approved inclusion/exclusion criteria is evaluated and verifies all inclusion criteria is met prior to enrolling the subject. The CRP version of this checklist is also available.

Recruitment Log: Tracks recruitment activities and used to evaluate which activities are most successful. For guidance in using template, click here.

Remuneration Log: Tracks all remuneration obtained by study staff and distributed to research subjects. Clinical Trial Subject Remuneration Vouchers can be found here.

Deviation Log: Documents and explains protocol deviations, and may be used to submit accumulated minor deviations to the CCI/IRB at the time of continuing review. An alternate version of template is available.

Exception Log: Documents and explains protocol exceptions, and may be used to submit accumulated minor exception to the CCI/IRB at the time of continuing review. An alternate version of template is available.